| CTRI Number |
CTRI/2022/07/044163 [Registered on: 20/07/2022] Trial Registered Prospectively |
| Last Modified On: |
06/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive type observational study |
| Study Design |
Other |
|
Public Title of Study
|
To find relevance and to identify the predictive value of the MRI findings in term of neurological recovery in an acute cervical spinal cord compression, cord haemorrhage and cord oedema caused by trauma |
|
Scientific Title of Study
|
An observational study of prognostic value of MRI markers in predicting neurological outcomes in post traumatic cervical spinal cord injuries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Negi |
| Designation |
PG Resident Doctor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of Physical Medicine and Rehabilitation SMS Medical College Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9599437952 |
| Fax |
|
| Email |
neginidhi135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Negi |
| Designation |
PG Resident Doctor |
| Affiliation |
Department of Physical Medicine and Rehabilitation,Sawai Man Singh Medical College, |
| Address |
Department of Physical Medicine and Rehabilitation SMS Medical College Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9599437952 |
| Fax |
|
| Email |
neginidhi135@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrinal Joshi |
| Designation |
senior professor |
| Affiliation |
Department of Physical Medicine and Rehabilitation,Sawai Man Singh Medical College |
| Address |
Department of Physical Medicine and Rehabilitation SMS Medical College Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412561906 |
| Fax |
|
| Email |
dr.m.joshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical college jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College Jaipur |
| Address |
Department of Physical Medicine and Rehabilitation SMS Medical College Jaipur 302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nidhi Negi |
SMS Medical College |
RRC building Department of Physical Medicine and Rehabilitation SMS Medical College and hospital
Jaipur
RAJASTHAN |
9599437952
neginidhi135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committe SMS Medical College Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S141||Other and unspecified injuries ofcervical spinal cord, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with post traumatic cervical spinal cord injury at department of PMR.
2. Patient’s aged 18 or more.
3. Patients with written and informed consent for being included in the study. |
|
| ExclusionCriteria |
| Details |
1. Brain injury or any other peripheral neurological injury.
2. Patients with other co-morbidities that interfere with MRI or neurological eg. Fluorosis, Ankylosis Spondylitis, Diabetics Neuropathy, GBS patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict the prognostic value of conventional MRI parameters in predicting neurological outcomes in post traumatic cervical spinal injuries (cord compression, cord oedema and cord haemorrhage).
|
At the time of admission, 15th,30th and 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the neurological outcomes using American Spinal Injury Association (ASIA) impairment scale |
At the time of admission, 15th,30th and 45th day. |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication details as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: -To identify the role of MRI findings in predicting
neurological outcomes in acute traumatic cervical spinal cord injuries
OBJECTIVES: - To predict the prognostic value of
conventional MRI parameters in predicting neurological outcomes in post
traumatic cervical spinal injuries (cord compression, cord oedema and cord
haemorrhage). To assess the neurological outcomes using American Spinal Injury
Association (ASIA) impairment scale |